There are several advantages with protein A affinity purification of monoclonal antibodies e.g. high robustness, selectivity and purity. A new protein A chromatography resin, MabSelect™ PrismA, has been developed which consists of a new high-flow agarose base matrix in combination with a new alkali-stabilized protein A ligand. Some of the key features include increased binding capacity and the possibility to use up to 1 M sodium hydroxide for cleaning-in-place and sanitization.<br/><br/>One side effect of protein A chromatography is that variable amount of ligand is eluted together with the product and there is a regulatory demand to control and quantify the protein A amounts through-out the purification process. As the MabSelect PrismA ligand is new there are no dedicated commercially available assay for the leakage, hence, five different commercial Protein A immunoassays are evaluated for detection and quantification of the new protein A ligand. In the commercial kits different variants of protein A are included. A comparison between the different assays in respect to quantification using existing standard and the new ligand will be made. Also, a comparison of ligand standard curve quality and dynamic range as well as experimental procedures will be made.

Evaluation of five commercial immunoassays for quantification of leaked ligand from a new protein A resin

255th National Meeting (2018)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.